The effect of a food supplement based on a mixture of herbal extracts on cellulite and weight control
| ISRCTN | ISRCTN87607337 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87607337 |
| Secondary identifying numbers | E.HU.039-0060.01.003L_2018/288 |
- Submission date
- 13/07/2018
- Registration date
- 24/07/2018
- Last edited
- 06/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Cellulite is a skin condition that can lead to skin imperfections, caused by uneven distribution of fat, It is seen most commonly in the thighs, hips and abdomen of both women and men. Exercise and a healthy diet can reduce the appearance of cellulite, but cannot completely eliminate it. Weight loss is key to reducing cellulite, whether this is achieved by diet or through exercising to burn calories and increase metabolism.
Herbal supplements can help to achieve weight loss faster than diet or exercise alone, as they increase the rate of burning fats. Some supplements containing compounds from plants can also help to reduce cellulite through removing toxins, draining fluids, reducing inflammation and firming and toning the skin, along with burning fat.
The aim of this study is to determine the efficacy of SelectSIEVE® Rainbow, a food supplement that contains a mixture of herbal and plant extracts including black rice, kiwi, orange and pineapple extract, on reducing the appearance of cellulite and on weight control.
Who can participate?
Healthy women aged 18-55 with cellulite and a BMI ranging from 23-30
What does the study involve?
Participants will be asked to take one capsule per day, containing either the food supplement (SelectSIEVE® Rainbow) or a placebo, for 56 days. Participants will be evaluated for changes in the appearance of their cellulite, skin elasticity and firmness, thickness of fatty layers and body measurements such as weight and circumferences. These measurements will be taken before starting the treatment, after 28 days and after 56 days. Participants will also be asked to take part in an interview for a self-assessment evaluation.
What are the possible benefits and risks of participating?
The possible benefit to participants is a reduction in the appearance of cellulite-related skin imperfections and a slimming effect. There are no known risks to participants, aside from a minimal risk of allergy or intolerance to the food supplement.
Where is the study run from?
Complife Italia S.r.l, Sam Martino Siccomario, Pavia, Italy
When is the study starting and how long is it expected to run for?
November 2017 to April 2018
Who is funding the study?
ROELMI HPC S.r.l (Italy)
Who is the main contact?
Dr Francesco Tursi
francesco.tursi@complifegroup.com
Contact information
Scientific
VIA GUIDO ROSSA 1
GARBAGNATE MILANESE (MI)
20024
Italy
 ORCID ID |
0000-0002-0055-5925 |
|---|---|
| Phone | +39 2 99025138 |
| francesco.tursi@complifegroup.com |
Study information
| Study design | Interventional double-blind placebo-controlled single-centre parallel group randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Randomized, double blind, placebo controlled clinical study for evaluating the efficacy of a food supplement on cellulite-derived skin imperfections and weight control |
| Study objectives | The present study is aimed to assess the efficacy of food supplement based on a mixture of herbal extract (SelectSIEVE® Rainbow), in ameliorating cellulite-derived skin imperfections as well as on the weight control. |
| Ethics approval(s) | Independent Ethical Committee for Non-Pharmacological Clinical Study Trials, 02/02/2018, ref 2018/01 |
| Health condition(s) or problem(s) studied | Cellulite-derived skin imperfections and localised adiposity at level of thighs/hip/waistline |
| Intervention | 60 healthy female participants were randomly allocated evenly into either the treatment or placebo group using a computer generated restricted randomisation list. Participants in the treatment group took capsules containing the active product (SelectSIEVE® Rainbow), a food supplement containing a mixture of herbal extracts, maltodextrins and natural dye. Participants in the placebo group took placebo capsules, where the active product was substituted by maltodextrins. Both groups took 1 capsule per day with a drink of water, either before lunch or their main meal, for 56 days. Participants in both groups were asked to follow a personalised alimentary diet, calculated in order to reduce their daily calorie intake by 300 kcal. Participants were also asked to use a body cream in place of their standard cream for body care. |
| Intervention type | Supplement |
| Primary outcome measure | The following outcomes were measured at day 0 (beginning of the treatment), day 28 and day 56 of treatment: 1. Cellulite-induced alteration of the skin microcirculation, measured by thermographic imaging 2. Clinical-dermatological evaluation of the cellulite-derived skin imperfections ("Orange peel" skin appearance ) carried out by a dermatologist in accordance to clinical scores 3. Thickness of the subcutaneous fatty layer measured by an ultrasound technique (using BX2000 BodyMetrix) 4. Skin elasticity and firmness, measured on the thighs by a Cutometer® |
| Secondary outcome measures | The following outcomes were measured at day 0 (beginning of the treatment), day 28 and day 56 of treatment: 1. Body weight by electric balance and height by stadiometer (for BMI determination) 2. Body circumferences (tights, hips, waistline) by a flexible meter 3. Evaluation of safety (adverse effects and tolerability) by monitoring adverse effects 4. Self-assessment evaluation, assessed using a 12 question questionnaire carried out after 28 and 56 days of treatment |
| Overall study start date | 10/11/2017 |
| Completion date | 03/04/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Good general health 2. Female 3. Caucasian ethnicity 4. Age between 18 and 55 years old 5. Mild to moderate cellulite-derived skin imperfections (grade II and III of the cellulite thermographic stage) 6. BMI between 23 and 30. 7. Not been recently involved in any other similar study 8. Willing to follow the proposed alimentary diet for all the study time 9. Willing to use only the cream consigned at the beginning of the study for body care 10. Willing to submit to before and after pictures 11. Willing to use only the food supplement during the entire study period 12. Willing to not use products likely to interfere with the food supplement 13. Willing to not vary the normal daily routine (i.e. lifestyle, physical activity, etc.) 14. Under effective contraception (oral/not oral) that is not expected to be changed during the trial 15. Aware of study procedures and signed informed consent form |
| Key exclusion criteria | 1. Pregnant or intending to become pregnant during study 2. Breastfeeding 3. Atopy (if this interferes with the study) 4. Allergic to ingredients of food supplements 5. Allergies to cosmetic products, toiletries, sunscreens and/or topical drugs 6. Following anti-cellulite treatment or have followed an anti-cellulite treatment less than 3 months before the study 7. Used sunbeds or self-tanning product for one month before study or intend to use it during the study 8. Using pharmacological treatment (local or systemic) that may interfere with study 9. Intending to initiate any intensive sport 10. Other diseases that may affect outcome of study, especially metabolic or endocrine (e.g. diabetes, liver disease, kidney disorders) or any other condition that the principal investigator deems inappropriate for participation 11. Protected by the law (under guardianship, hospitalised in a public or private institution or incarcerated) 12. Unable to communicate or cooperate with the investigator |
| Date of first enrolment | 05/02/2018 |
| Date of final enrolment | 07/02/2018 |
Locations
Countries of recruitment
- Italy
Study participating centre
San Martino Siccomario (PV)
27028
Italy
Sponsor information
Industry
Via Celeste Milani 24
ORIGGIO (VA)
21040
Italy
| Website | https://roelmihpc.com/ |
|---|
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Data will published in relevant international peer reviewed journals. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository on a proprietary server. Tables and pictures will be shared and will become available after editing and sending the final report to the sponsor. Datasets will be available for 10 years. The prinicipal investigator and control authorities (on request) can access data for analyses including anthropometric measures, calculations and pictures. Access will be granted via a personal password. Consent from participants was obtained and all data is anonymised through coding. There are no ethical or legal restrictions. |
Editorial Notes
06/11/2019: Internal review.
